EP0693955B1 - Vorrichtung zur endomitrialen ablation - Google Patents

Vorrichtung zur endomitrialen ablation Download PDF

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Publication number
EP0693955B1
EP0693955B1 EP94914032A EP94914032A EP0693955B1 EP 0693955 B1 EP0693955 B1 EP 0693955B1 EP 94914032 A EP94914032 A EP 94914032A EP 94914032 A EP94914032 A EP 94914032A EP 0693955 B1 EP0693955 B1 EP 0693955B1
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EP
European Patent Office
Prior art keywords
electrode
power
electrodes
temperature
balloon
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EP94914032A
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English (en)
French (fr)
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EP0693955A4 (de
EP0693955A1 (de
Inventor
Roger A. Stern
Vincent N. Sullivan
Robert L. Marion
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Covidien AG
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Sherwood Service AG
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    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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Definitions

  • the present invention relates to an apparatus for in situ destruction of the inner lining of body organs, and more particularly the providing of a selective destruction of the endometrium as an alternative to hysterectomy for treatment of uterine bleeding.
  • Prior techniques for removing or destroying the inner lining of body organs have been explored in order to provide for an alternative to surgical removal of the body organs for treatment of diseases and other abnormal conditions.
  • Prior techniques involved the destructive treatment of the inner linings with chemicals and with various forms of thermal energy such as radio frequency, microwave heating, cryotherapy, laser surgery and electrosurgery. Radio frequency and microwave energies have also been applied directly to the linings to generate heat in situ.
  • balloon catheters have been supplied with a heated fluid for thermal ablation of hollow body organs as described in US-A-. 5,045,056.
  • application of microwave and high frequency RF energy to body areas to destroy body tissue, using single electrodes enclosed in expanded balloons have been described in US-A-4,662,383 and 4,676,258.
  • the expandable balloon is filled with an electrically non-conductive medium and a RF current is passed through substantially the entire surface of the endometrium.
  • the current is sufficient to resistively heat the endometrium in a single operation to a temperature within a range of between 45°C to 90°C for a time sufficient to destroy the cells of the lining while maintaining the average temperature of the myometrium at a temperature of substantially 42°C or less.
  • the RF current has a frequency of at least 250 kHz and less than 100 MHz.
  • the conductive, expandable member is inserted in its unexpanded state into the uterine cavity through the cervical opening and subsequently expanded to establish surface contact with the endometrial surface and RF current is applied to the member in its expanded condition.
  • a plurality of throughholes throughout the electrodes and thermistors on its other surface may be provided. One of each plurality of holes passes through the bladder to form an electrical continuity with its other surface, to which a power lead comes and extends also to the respective thermistor.
  • the array of separate electrodes and associated separate thermistors on the bladder, with a series of power leads with each power lead delivering power to a single electrode and to its associated thermistor provides a temperature feedback for temperature regulation of the endometrial ablation.
  • FIG. 1 a cross-sectional representation shows an electroconductive balloon as the expandable member with Figure 2 representing the same apparatus as Figure 1 prior to inflation of the balloon element.
  • the uterus 2 consists of myometrial tissue 4 surrounding the uterine cavity.
  • the normal uterine cavity or envelope is a flat cavity having approximately the shape of an inverted triangle with the two upper corners communicating with the ovaries by way of the fallopian tubes 6 in the bottom corner opening into the cervical canal 8.
  • the entire surface of the envelope includes the entrance of the fallopian tubes 6 and the cervical canal 8 which is covered with a thin layer of tissue known as uterine endometrium.
  • the selective destruction of the endometrial cells is the goal of the improved apparatus disclosed in this present invention.
  • the monopolar electrode system developed in conjunction with Figure 1 expands to conform to the endometrial surface to be treated and this in turn dilates and stretches the endometrium to reduce surface folds.
  • Radio frequency electric current passes through the dilated endometrial surface for a time sufficient to destroy the endometrial cells by elevating the temperature of the endometrium to between 45°C and 90°C, and preferably within 10 seconds. The temperature is maintained until the endometrial tissue is destroyed which is optimally accomplished by a temperature between 55°C to 65°C for up to 10 minutes.
  • the electric current passes through or along the surface of the expandable member and the interior of the expandable member is filled with an electrically non-conductive substance such as a fluid or gas.
  • the expandable member can be any material or article which can be compressed or otherwise prepared in a small diameter configuration for insertion through the cervix and expanded or inflated after insertion to provide the dilation. This expandable member establishes direct electrical connection or capacitive coupling with the endometrium. A second electrical contact can occur by way of grounding plates or patches which contact a large area of the patient's skin in order to complete the electrical circuit.
  • the inflatable balloon or bladder is inserted into the uterine cavity 15 as shown in Figure 2 and subsequently the inflation of the balloon occurs with a gas or a non-conductive liquid so that it extends and fills the uterine cavity conforming to the expanded surface as shown in Figure 1.
  • Portions of the balloon 14 extend into the entrance to the fallopian tubes 6 and extend along the entire endometrial surface 12 to the cervix 8.
  • the balloon is attached to and forms a fluid-tight seal with the tube 16 which encloses a smaller fluid delivery tube 18 as well as an electrical cable 20 containing leads for the conductor as well as additional leads for the sensors.
  • a plurality of temperature sensors 24 are shown attached to the inner surface of the balloon. Alternatively, this lead configuration can be replaced by lead pairs 22 for each sensor.
  • the temperature sensors 24 are conventional thermistors or thermocouples and are positioned on zones of the balloon which will contact areas of the endometrial surface which are most sensitive to overheating.
  • the temperature sensors can also be fiber optic temperature sensors.
  • the fluid delivery tube 18 is connected to a source of gas or liquid through a conventional fluid control system which will be later illustrated in conjunction with Figure 13.
  • the Figure 3 is an enlarged cross-section illustrating the relationship between a small segment of uterine endometrium and the expandable balloon element of the Figure 1.
  • the endometrial lining 12, supported on the myometrium 4 is typically an irregular surface even after it is extended by the inflated balloon element 14.
  • Electrical contact between the conductive surface 35 on the outer surface of the balloon 14 and the endometrium 12 can be improved by covering the outer surface of the balloon with a conventional electroconductive solution, paste or gel 37 which is physiologically non-toxic and nonirritating.
  • Suitable electroconductive media including the known types of gels and pastes used as surface coatings for defibrillators may be used.
  • Suitable conductive gels are carboxymethylcellulose gels made from aqueous electrolyte solutions such as physiological saline solutions and the like.
  • the electroconductive solution, paste or gel enhances electrical contact between the balloon and the endometrium by filling the pores of the balloon surface and the irregularities in the endometrial surface.
  • the expandable balloon or bladder can be an elastomeric polymer such as a natural or synthetic rubber made conductive by mixing the polymer with electroconductive particles such as carbon or conductive metal particles. Alternately, it may be made conductive by a surface coating of electroconductive material such as an electroconductive gel, or a conductive metal coating on the outer or inner surface of the balloon or bladder wall. Electroconductive coating can be applied to organic polymer surfaces by conventional vapor deposition, electrical depositions, sputtering and the like.
  • a preferred balloon comprises a thin, non-extensible polymer film such as a polyester or other flexible thermoplastic or thermosetting polymer film, for example, having a conductive metal coating on the outer or inner surface thereof.
  • the films form a non-extensible bladder having a shape and size, in its fully expanded form, which will extend the organ and effect contact with the endometrial lining to be destroyed.
  • the inner surface of the non-extensible bladder can be coated with electroconductive material which will capacitively couple to the endometrium provided that the bladder wall thickness is less than approximately 0.25 mm.
  • the surface of the expandable member can be an open-cell, porous material such as a foam or similar caged network of material which can hold a quantity of the electroconductive solution, paste or gel required to secure satisfactory electrical contact with the opposed endometrial surface.
  • the surface can be coated with or impregnated with the electroconductive substance.
  • FIG 4 illustrates a prior art balloon with a plurality of surface segments as the expandable bladder member 39.
  • Each of the surface segments has a conductive surface and a temperature sensor.
  • the balloon has a segmented electrode coating of electroconductive metal on either the inner or the outer surface to permit controlled delivery of power to each segment.
  • Each segment 40 is electrically connected through conventional leads to a power source (not shown in Figure 4).
  • Each conductive segment 40 also has a thermistor 42 which is connected through conventional leads to a switch matrix.
  • Figure 4B illustrates a top view of the bladder electrode 39 and particularly features a lumen 44 extending through the center of the bladder electrode. The lumen allows for light guides to be inserted through the center of the electrode. In other words, there is an inner lumen tube 44 attached to the center of the flat film.
  • FIG. 5 is a schematic representation of the power source controller and the switch matrix for the multi-segment balloon discussed above in conjunction with, for example, Figure 4.
  • the electrical leads connect to the electro-thermistor pairs of the bladder of Figure 4 by way of connectors 138 as shown in Figure 5.
  • the thermistor leads are connected to the matrix switch bank 134 and the electrode leads are connected to the switch bank 136.
  • Each thermistor (Fig. 4a) 42 is sampled by means of the temperature measurement circuitry 128 and the isolation amplifier 126 before being converted in the converter 116 and fed to the computer 114.
  • the temperature measurement circuitry compares the measured temperature with a thermistor reference voltage 132.
  • the electrode switch 136 is controlled in response to the output of the computer 114 by means of the opto-isolators 132.
  • Input power from the RF input passes through the overvoltage and overcurrent protector 110 and is filtered by the bandpass filter 122 before being subjected to overvoltage suppression by the suppression unit 124.
  • the voltage is isolated by means of the transformers 138, 140 and 142 with the transformer voltages V i and V v from the transformers 142 and 144 being converted by the RMS-DC converters 118 into an RMS voltage to be fed to the converters 116.
  • the signals V i and V v Prior to conversion, the signals V i and V v are also fed to a high-speed analog multiplier 120 RF control from computer 114 is provided through interface 112.
  • FIG. 6 A variation of the electrode structure of Figure 4 is shown in Figure 6 wherein there are perforated electrodes 150 illustrated with their power traces 152.
  • This particular electrode bladder of Figure 6 is shown with the perforated electrode 150 on the exterior of the bladder.
  • Figure 7 illustrates thermistor common-side traces 154 on the interior of the bladder with circular wiring jumping pads 156 with mounting sites 157 serving as the base for the thermistors.
  • the common-side traces provide power for both the electrodes and the associated thermistor.
  • the Figure 7 illustrates both interior sides of the bladder.
  • Figures 8a-b illustrate both the outside and the inside of a double-sided electrode with thermistor traces having perforated electrodes 160 on the outside and thermistor wiring pads 162 and electrode power leads 164 as well as thermistor mounting sites 166 on the inside.
  • the connection between the inside and outside of the bladder is shown by the continuity labeled Via in the Figures 8a and 8b.
  • Figure 8b specifically shows a cross-sectional view of the bladder with the electrode 160 on the top or outside surface and the power traces 164 and thermistor wiring pad and mounting site 166 on the lower or inside surface.
  • Figure 8b illustrates the mounting of the thermistor 163 on the mounting site 166 with a connection between the power trace and the thermistor being made by the thermistor lead 169.
  • Figure 8b clearly illustrates that all except one of the holes in the perforated electrode 160 have a depth which reaches to the substrate or bladder 174.
  • the one hole labelled Via extends through the entirety of the bladder as an electrical connection between the perforated electrode 160 and the power trace 164 on the bottom or inside surface.
  • Figure 8a embodiments corresponds to a combination of the inside illustration of the power traces and the bonding surfaces from Figure 7 along with the perforated electrode of Figure 6 with the exception that Figure 8a has the power traces on the inside surface whereas the embodiment of Figure 6 has the power traces for the perforated electrodes on the outside surface.
  • FIG. 6 Each of the views of Figures 6, 7 and 8, whether on the inside or the outside must be understood to represent only two surfaces of a bladder which must necessarily have four surfaces.
  • the bladder, prior to inflation, can be envisioned as triangular with two outside triangular surfaces (top and bottom) and two inside triangular surfaces prior to inflation.
  • Electrode structure according to the invenction is shown in Figure 9 which illustrates a flat metallized stock material adhesively bonded as electrodes 170 and 172 to the outside of both the top and the bottom of the bladder.
  • the electrodes which are metallized and adhesively bonded, form a serpentine electrode pattern in order to promote uniform heating of the area.
  • Figures 10A and B illustrate the bladder application device which is used to insert the bladder electrode constructed in accordance with any one of the embodiments discussed above.
  • Figure 10B is a side view of the application device illustrating a sheath applicator with a main tube and a shrink wrap covering the wiring leads. A fiber bundle is located in the center of the applicator which would be connected through the lumen illustrated in Figure 3, for example.
  • the applicator device 175 has an inflation inlet 176 and an electrode wiring insertion port 177 as well as the optical viewing fiber inlet 178 through a lumen. Movement of the bladder electrode 180 is controlled by an alignment guide and the sheath retraction knob acting in conjunction with a thumb detent 182.
  • the applicator of Figure 10A shows the bladder electrode in an extended but unexpanded position.
  • Figures 11a-c illustrate the bladder device of Figure 10 in a retracted position with Figures 11b and 11c being taken at the cross sections titled A-A' and B-B' respectively.
  • Figure 11c illustrates the position of the deflated bladder with respect to the main tube in the retracted position at line B-B'.
  • the remaining features of the applicator 175 remain as indicated with respect to Figure 10.
  • FIG. 12 An illustration of the connection of the application device 175 and the electrode balloon 190 in accordance with any one of the embodiments of the Figures 6-9 is illustrated in Figure 12.
  • An inflation pump 193 provides the medium for the expansion of the balloon 190 while the electrode belt 195 provides the reference electrode for connection to the control system 100.
  • RF generator 197 serves as the RF input power for the control system schematic of Figure 5 by means of electrosurgical interface cables 199.
  • Control modules 203 and interface control 204 connect with computer 114.
  • the RF electrodes are separately, independently and sequentially energized with thermistor temperature feedback to bring the endometrial temperature up to a desired level.
  • the system accomplishes this in an automated manner based upon the output from a conventional electrosurgical power supply 197.
  • the electrodes may have a variety of specific configurations and heating is concentrated in the endometrium at the surfaces of the electrodes due to the various illustrated electrode configurations in order to provide uniform heating.
  • An example of the concentration of the heat over the entire surface of the electrode is available from the embodiment wherein holes are provided through the electrode as shown in Figures 6 and 8. Uniform heating is also obtained by extending the electrodes in a pattern of lines such as the serpentine pattern structure of Figure 9.
  • the treatment method as well as the electrode elements provide an increased current density as a function of the "electrode edge length" available for heating.
  • the electrodes can be on the outer surface of the bladder while the power traces, thermistors, and thermistor leads can be on the other surface of the bladder.
  • the various electrode pattern feature common power traces for both the electrodes and the associated thermistors. That is, one power lead provides the power for an individual electrode as well as its associated thermistor thereby saving in the construction of the bladder electrodes by reducing the number of required thermistor leads by one-half.
  • each electrode has a corresponding thermistor lead in common with the RF power lead.
  • the second leads from all thermistors are then connected together to form a thermistor common as shown for example in the Figures 7 and 8a. This arrangement provides the advantage that it only requires N+1 leads to drive an ablation balloon with N electrodes and N thermistors.
  • the temperature measurement circuitry 128 of Figure 5 has additional requirements beyond the construction with a separate power lead for each thermistor and for each individual electrode.
  • the construction with separate power leads for the electrodes and the thermistor are well known and any one of a variety of temperature measurements schemes for individual electrodes could be utilized.
  • RF power is selectively applied through switch matrix 210 so that it can be applied to selected electrodes.
  • the electrode/thermistor circuitry is represented on the right hand side of the Figure generally as 220 with a particular example being given by three electrodes and three thermistors represented by resistors 222, 224 and 226.
  • a reference voltage Vref is buffered by an operational amplifier follower 232 and passes through resistor 233 before entering the measurement switch matrix 240.
  • the output of resistor 233 is buffered by operational amplifier 234.
  • Outputs of the measurement switch matrix 240 are fed through the filters 244, 246 and 248 which represent low pass filters which block high frequency RF but pass DC and very low frequency voltages.
  • the balloon thermistor common lead 227 passes through the filter 249 to ground.
  • RF power is applied to a particular desired electrode or electrodes by operations of the RF power switch matrix 210.
  • Measurement of thermistor resistance 222, 224 or 226 is independent of the particular electrodes connected to the RF power.
  • measurement switch matrix 240 is set up to connect lead 1 to the right hand side of resistor 233 while all other leads are set to be connected to the output of the follower 234. This particular set up and arrangement forces the voltage VT to be equal to V REF . RT1/(Rb+RT1). Therefore this allows the measurement of RT1 due to the known value of Rb and V REF . Because the other leads 2, 3 from the circuitry 220 are held at the same voltage by the follower 234, there are no voltage differences between any of these leads and therefore no current will flow between them.
  • the bladder electrodes are constructed in accordance with a method wherein a double-sided thin flat film is plated on one side to increase the electrode thickness and a deposit mask is provided for an electrode pattern on the thick side using lithographic techniques. Then a mask is deposited for the conductors which lead to the temperature sensing elements on a second side. Subsequently, non-masked conductors are etched away leaving the desired pattern.
  • the thermistors (Fig. 4a) 42 are provided using surface mounting techniques and the attached inner lumen is provided at the center of the flat film.
  • the balloon is then folded and sealed to the main tube at the proximal end with the inner and outer concentric tubes sliding with respect to each other as illustrated in the Figure 10.
  • conductors are brought to the outside of the main tube to the end of the device near the handle of the applicator.
  • the outer tube is placed over the conductor and heat-shrunk as shown in Figure 10b.
  • the handle of the applicator of Figure 10 or Figure 11 is assembled.
  • an electrode balloon may be used such as utilizing a blow molded preform or the formation of the balloon with copper on kapton conductive elements on the surface of a compliant balloon. Furthermore, this balloon may be formed as a "sock" to fit over the inner latex balloon with the sock being a compliant device. Other anticipated forms of an electrode balloon structure include the use of the plated or etched wiring all the way from the balloon itself down to the handle.
  • Utilizing the present invention allows for the use of low accuracy thermistors wherein calibrations can be stored in memory chips in the handles of the device.
  • the attachment of the electrodes to the bladder can be accomplished by conductive adhesive or by soldering.
  • the applicator of Figures 10 and 11 can be deployed by pulling the front end of the balloon back inside and collapsing the balloon around it.
  • the pattern can be formed with particular kinds of spines for the sheath in order to aid in the folding of the patterned electrode within the applicator.

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Claims (5)

  1. Endometriumablationsapparat für die selektive Zerstörung der Endometriumauskleidung eines Körperorgans, wobei der Apparat Folgendes umfasst:
    einen von Hand gehandhabten Applikator (175) für das manuelle Steuern einer eingeschlossenen, expandierbaren, ausziehbaren Elektrodenkonstruktion (180), wobei dieser Applikator einen Einlass (176) aufweist für die Aufnahme eines elektrisch nichtleitenden Expansionsmediums und das Übertragen des Expansionsmediums an die expandierbare Elektrodenkonstruktion, wenn die Konstruktion sich in ausgezogener Position befindet, wobei der Applikator des weiteren einen Stromquelleneingang (177) für das Übertragen der elektrischen Stroms an die Elektrodenkonstruktion (180) enthält,
    die expandierbare Elektrodenkonstruktion (180) mit einer Vielzahl einzelner Elektrodenbereiche (170, 172) und einem Thermistor (163) ausgestattet ist, der mit jeder der Vielzahl einzelner Elektrodenbereichen (170, 172) assoziiert ist und des weiteren eine Vielzahl von Elektrodenstromverbindungen (164) enthält, wobei jede der Verbindungen elektrisch an einen entsprechenden Bereich unter der Vielzahl der einzelnen Elektrodenbereiche und einen entsprechenden Thermistor unter den Thermistoren angeschlossen ist, wobei die Elektrodenbereiche (170, 172) ein Serpentinenmuster bilden.
  2. Endometriumablationsapparat nach Anspruch 1, der des weiteren Folgendes umfasst:
    eine Stromversorgungsvorrichtung (197), die an den Stromquelleneingang angeschlossen ist, und
    ein elektrisches Rückführregelsystem (203, 204), das eine Temperaturregelvorrichtung enthält, die auf die Temperatur der Elektrode anspricht, um die Ausgabeleistung der Stromversorgungsvorrichtung zu regeln.
  3. Endometriumablationsapparat nach Anspruch 1 oder Anspruch 2, der des weiteren eine Temperaturmessvorrichtung enthält, die eine erste Schaltmatrix (210) für das selektive Aufbringen des elektrischen Stroms auf mindestens eine der Vielzahl der Elektrodenstromverbindungen, eine erste Bezugsspannung (Vref), eine zweite Bezugsspannung (VT) und eine zweite Schaltmatrixvorrichtung (240) für das Verbinden einer ausgewählten Elektrodenverbindung von mindestens einer dieser Elektrodenverbindung an die erste Bezugsspannung enthält, während sie gleichzeitig alle anderen der Elektroden an die zweite Bezugsspannung anschließt.
  4. Endometriumablationsapparat nach einem der Ansprüche 1 bis 3 für die Bereitstellung eine elektrischen Kontakts mit einer Endometriumauskleidung der Gebärmutter zum Zweck des Zerstörens der Endometriumauskleidung, wobei die Einheit Folgendes umfasst:
    eine expandierbare Blase (174) mit einer Innenfläche und einer Außenfläche, wobei eine der Innen- und Außenflächen mit einer Vielzahl einzelner Elektrodenbereiche (160) ausgestattet ist und die andere der Innen- bzw. Außenflächen mit einer Vielzahl von Thermistoren (163) ausgestattet ist, von denen jeder der Vielzahl der Elektroden entspricht,
       wobei jede der Vielzahl von Elektroden des weiteren eine Vielzahl an Öffnungen umfasst, wobei eine der Vielzahl von Öffnungen sich von der Außenfläche zur Innenfläche durch die Blase erstreckt und die ausgezogenen Öffnung eine elektrische Kontinuität bietet zwischen jeder Elektrode und der anderen Fläche,
       wobei die andere Fläche eine Stromverbindung (164) für jede der Elektroden enthält, wobei die Verbindungen sich von einem Ende der Blase zu einer entsprechenden ausgezogenen Öffnung erstrecken, wobei die Stromverbindung sich auch zum entsprechenden Thermistor (163) erstreckt,
       wobei das Verhältnis zwischen der Vielzahl von Öffnungen in jeder der Elektroden und Stromverbindungen eine gleichmäßige Erwärmung auf einer Fläche jeder der entsprechenden Elektroden bietet.
  5. Endometriumablationsapparat nach Anspruch 4, bei dem jeder der Thermistoren (163) des weiteren an eine gemeinsame Erdungsverbindung (227) auf der anderen Fläche angeschlossen ist.
EP94914032A 1993-04-14 1994-04-11 Vorrichtung zur endomitrialen ablation Expired - Lifetime EP0693955B1 (de)

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US08/046,683 US5443470A (en) 1992-05-01 1993-04-14 Method and apparatus for endometrial ablation
US46683 1993-04-14
PCT/US1994/003695 WO1994023794A1 (en) 1993-04-14 1994-04-11 Method and apparatus for endometrial ablation

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EP0693955A1 EP0693955A1 (de) 1996-01-31
EP0693955A4 EP0693955A4 (de) 1998-01-07
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JP (1) JP3566722B2 (de)
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CA (1) CA2159483C (de)
DE (1) DE69431950T2 (de)
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ATE230284T1 (de) 2003-01-15
US5713942A (en) 1998-02-03
JPH08508912A (ja) 1996-09-24
AU6625594A (en) 1994-11-08
IL109296A0 (en) 1994-07-31
US5443470A (en) 1995-08-22
WO1994023794A1 (en) 1994-10-27
ES2189801T3 (es) 2003-07-16
CA2159483A1 (en) 1994-10-27
JP3566722B2 (ja) 2004-09-15
CA2159483C (en) 2000-02-22
DE69431950D1 (de) 2003-02-06
DE69431950T2 (de) 2003-11-13
TW295539B (de) 1997-01-11
EP0693955A4 (de) 1998-01-07
EP0693955A1 (de) 1996-01-31
US6041260A (en) 2000-03-21

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